One-Third of Women Using Bisphosphonates at Risk for Fracture

According to the June 6, 2016 news release, “Research from the Regenstrief Institute-Merck (Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) collaboration suggests that many women still have indicators consistent with higher risk of fracture while taking these medications. The cross-sectional population health study was based on a retrospective database analysis of 7, 435 women age 50 and older taking bisphosphonates for at least two years during the 2000-2012 time period.” Specifically, the study found that “approximately a third of women prescribed these drugs continue to be at elevated risk for bone fracture, an outcome that may have several origins.” The analysis was published in the peer-reviewed journal Bone.

“While we found that a substantial proportion of patients who took oral bisphosphonates remain at risk for hip, spine, and other major fractures, this class of drug does improve bone density in the majority of patients and should remain a mainstay of osteoporosis management, ” said Erik Imel, M.D. in news release. Dr. Imel is the Indiana University School of Medicine endocrinologist and Regenstrief Institute-affiliated scientist who led the study.

“We limited our study to patients who were considered to be compliant with taking their medication, based on drug dispensing days covered, with the presumption being that those who filled prescriptions took the medication properly. We would expect even less benefit if patients fail to take their medication properly. To increase treatment effectiveness, patients and their doctors should be vigilant that the drug is taken reliably and properly. However, osteoporosis drugs are not enough. Physicians and their patients are well advised to discuss additional important modifications to decrease fall risk and fracture risk. These include exercise, smoking cessation, use of assistive devices such as canes or walkers, modifying the home to avoid obstacles that might lead to falls, and taking appropriate amounts of vitamin D and calcium.”

“We know that taking bisphosphonates decrease fracture risk compared to those not taking these drugs, ” Dr. Imel said. “But what about those women who weren’t getting the anticipated benefit and are not improving bone density or even are losing bone density? What predicted that? The purpose of this study was to focus attention on those not doing well, in order to begin to decrease the odds of future fractures in this large group of vulnerable patients.

Dr. Imel told OTW, “I think the most challenging aspect of this work was that most people are not adherent, so limiting to an adherent population (who should benefit the most from the drug) limited the population further. I would expect that a non-adherent population would be even worse in terms of response.”

“I think that the most important message for orthopedic surgeons is that there are effective medications for osteoporosis, but patients need to take them reliably for benefit; and the medications are not the only important factors. Fracture prevention should be multi-modal. Patients also need to engage in general health behaviors and in behaviors to decrease risk of falling as well. Patients fracturing while on an osteoporosis medication might be candidates to consider different osteoporosis drugs, though these approaches were not formally tested in this study.”